Assessing Research Ethics Committees in Myanmar: Results of a Self-Assessment Tool.

BACKGROUND: Human subject research has increased in Myanmar since 2010 and accordingly, the establishment of research ethics committees (RECs) have increased to review these research studies. However, characteristics that reflect the operations of RECs in Myanmar have not been assessed. OBJECTIVES: To assess the structures and processes of RECs at Medical Institutions in Myanmar. METHODS: We used a self-assessment tool for RECs operating in low and middle-income countries. This tool consists of the following ten domains: organizational aspects, membership and ethics training, submission arrangements and materials, meeting minutes, policies referring to review procedures, review of specific protocol and informed consent items, communication a decision, continuing review, REC resources, and institutional commitment. We distributed this self-administered questionnaire to RECs from 15 Medical Institutions in Myanmar and one representative from each REC completed this questionnaire and returned it anonymously. We used descriptive, bivariate, and multivariate statistics to analyse the data. RESULTS: Out of maximum 200 points, the total mean score for Myanmar Medical Institutions was 112.6 ± 12.77, which is lower compared to the aggregate mean score of 137.4 ± 35.8 obtained from RECs in other countries. Domains in which the average percentage score was less than 60% included organizational commitment, membership and ethics training, continuing review and REC resources. Many RECs have a diverse membership and appropriate gender balance but, lacked essential policies. CONCLUSION: The results show that for Myanmar RECs there is significant room for improvement in their "structures and processes" as well as the extent of institutionl commitment. The self-assessment tool proved to be valuable method to assess the quality of RECs.

Current Status of Research Ethics Capacity in Myanmar.

Myanmar has recently surfaced from total military rule and efforts at conducting research to enhance the health of the population has increased during the recent democratization process, both from the military and civil sectors as well as support from international agencies. International guidelines mandate that such research requires prior ethics review in accordance with international standards. Previous commentators have expressed concerns, however, regarding the degree of adequate training in research ethics for investigators, the optimal functioning of Research Ethics Committees (RECs), and the extent of responsible conduct in research in low and middle-income countries. Such concerns might also be applicable to Myanmar, especially since it has recently emerged from a long period of military rule where there has been lack of basic freedoms and human rights abuses. We herein review the current gaps in research ethics capacity in Myanmar, the status of the existing RECs and the current efforts to establish training programs to enhance capacity in research ethics.

Cellular Mutagenicity and Heavy Metal Concentrations of Leachates Extracted from the Fly and Bottom Ash Derived from Municipal Solid Waste Incineration.

Two incinerators in Taiwan have recently attempted to reuse the fly and bottom ash that they produce, but the mutagenicity of these types of ash has not yet been assessed. Therefore, we evaluated the mutagenicity of the ash with the Ames mutagenicity assay using the TA98, TA100, and TA1535 bacterial strains. We obtained three leachates from three leachants of varying pH values using the toxicity characteristic leaching procedure test recommended by the Taiwan Environmental Protection Agency (Taiwan EPA). We then performed the Ames assay on the harvested leachates. To evaluate the possible relationship between the presence of heavy metals and mutagenicity, the concentrations of five heavy metals (Cd, Cr, Cu, Pb, and Zn) in the leachates were also determined. The concentrations of Cd and Cr in the most acidic leachate from the precipitator fly ash and the Cd concentration in the most acidic leachate from the boiler fly ash exceeded the recommended limits. Notably, none of the nine leachates extracted from the boiler, precipitator, or bottom ashes displayed mutagenic activity. This data partially affirms the safety of the fly and bottom ash produced by certain incinerators. Therefore, the biotoxicity of leachates from recycled ash should be routinely monitored before reusing the ash.

Evaluating the mutagenicity of leachates obtained from the bottom ash of a municipal solid waste incinerator by using a Salmonella reverse mutation assay.

The mutagenic potential of leachates derived from the bottom ash of a municipal solid waste incinerator in Taiwan were evaluated using an Ames Salmonella mutagenicity assay with three standard tester strains, TA98, TA100, and TA1535. Three types of leachants, leachant A (pH 4.93), leachant B (pH 2.88), and leachant C (deionized water, pH 6.0), were carried out according to toxicity characteristic leaching procedure (TCLP). Moreover, two types of bottom ash, nonsieved and sieved bottom ash (particle size <4.75 mm), were analyzed with the TCLP and the Ames assay. The concentrations of five heavy metals (Cd, Cr, Cu, Pb, and Zn) in the leachates were also estimated with an ICP-OES. The results indicated that the metal concentrations in the TCLP leachates of bottom ash were all below the limits set by Taiwanese regulations. However, leachate A from nonsieved and <4.75-mm-sieved bottom ash showed mutagenicity. Moreover, leachate A from <4.75 mm-sieved bottom ash displayed stronger mutagenicity than that from nonsieved ash. The leachate A from <4.75-mm-sieved bottom ash, that were diluted by 100-fold showed no mutagenicity. In conclusion, our results suggested that the chemical composition and mutagenic potential of leachates should be monitored to evaluate the safety of bottom ash.